This chapter governs the coverage of services for the Medical Assistance Family Planning Program. Eligibility shall be established according to COMAR 10.09.37. In this chapter, the following terms have the meanings indicated. Terms Defined. “Advanced practice nurse” means an individual who meets the requirements in COMAR 10.09.01. “Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01. “Early and Periodic Screening, Diagnostic and Treatment (EPSDT)” means the provision to individuals younger than 21 years old, of preventative health care under 42CFR §441.50 et seq. as amended, and other health care services, diagnostic services, and treatment services that are necessary to correct or ameliorate defects and physical and mental illnesses and conditions discovered by EPSDT screening services. “Family planning” means providing individuals with the information and means to prevent unwanted pregnancy and maintain reproductive health. “Free-standing clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home, and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services. “Hospital” means an institution that is licensed pursuant to COMAR 10.07.01, or other applicable standards established by the state in which the service is provided. “Local health department (LHD)” means the Baltimore City Health Department and its subgrantees, or a county health department and its subgrantees. “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. “Medical laboratory” means a licensed or certified facility, place, establishment, or institution, operated for the examination of material derived from the human body, by means of one or more of the scientific disciplines, for the purpose of obtaining scientific data that may be used to determine the presence, source, progress, or identity of disease agents, and to aid in the prevention, diagnosis, treatment, and management of human disease. “Medically necessary” has the meaning stated in COMAR 10.09.36.01. “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Participant” means an individual who is certified as eligible for the Family Planning Program as described in COMAR 10.09.37. “Pharmacy” means an establishment or institution requiring a permit in accordance with Health Occupations Article, Title 12, Annotated Code of Maryland, or similar establishment or institution which is legally authorized to dispense legend drugs to the public in the state in which the establishment or institution is located. “Physician” means an individual licensed to practice medicine in the state in which the physician's practice is located. “Physician assistant” means an individual who meets the requirements in COMAR 10.09.55. “Physician office and other point-of-care laboratory” means a medical laboratory at a site or facility operated as a part of, or in association with, the medical practice of licensed medical practitioners permitted to perform clinical laboratory procedures, community health center, emergency treatment center, health maintenance organization, or county or local health department, where clinical laboratory procedures are performed for patients seen by the practitioner or a practitioner employed or otherwise engaged by one of these entities. “Program” means the Maryland Medical Assistance, Family Planning Program. “Provider” means a health care provider who: Meets the licensure requirements set forth in Regulation .03 of this chapter; Meets the conditions for participation set forth in Regulation .04 of this chapter; and Provides the services described in Regulation .05 of this chapter. An advanced practice nurse shall be licensed to practice as described in COMAR 10.09.01. A doctor of medicine or osteopath shall be licensed and legally authorized to practice medicine in the state in which the service is delivered as described in COMAR 10.09.02. A physician assistant must be licensed to practice as described in COMAR 10.09.55. Medical laboratories shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and, if located: In Maryland or out-of-State with representation or specimen pick-up in Maryland, comply with the requirements of Health-General Article, §§17-202, 17-212, and 17-214.1, Annotated Code of Maryland, and COMAR 10.10.01; or Out-of-State without representation or specimen pick-up in Maryland, comply with other applicable standards established by the state and locality in which the services are provided. A pharmacy may not qualify as a provider without first having obtained a permit from the: Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland; or Appropriate agency in the state in which the pharmacy is located. Physician office and other point-of-care laboratories shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and, if located: In Maryland, comply with the requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or Out-of-State, comply with other applicable standards established by the state and locality in which the services are provided. Providers shall be enrolled as Medical Assistance Program providers and shall meet the requirements for participation in the Maryland Medical Assistance Program as set forth in COMAR 10.09.36.03, as well as the requirements for participation as set forth in the COMAR chapter defining the provider and covered service being rendered. Services covered in Regulation .05A—C of this chapter shall be provided by: A physician; An advance practice nurse; or A physician assistant. Providers shall accommodate the cultural and ethnic diversity of the populations to be served. The following services are covered under this chapter: Office medical visits for the primary purpose of providing age and sex appropriate family planning services, which include: Focused history, physical exam, and laboratory testing necessary to evaluate and manage the participant’s choice of chemical, mechanical, or other method to prevent conception; Basic education regarding human sexuality and reproduction; Advice and counseling regarding all family planning methods, including natural family planning measures and sterilization procedures, the availability and effectiveness of methods, procedures involved in each, and untoward effects and potential complications of each method; and Referral mechanism and documented referral for all patients demonstrating illness, disease, or pregnancy; Specimen collection by venipuncture or capillary puncture when performed by either the medical practitioner or the laboratory; Pregnancy test if indicated by physical examination or history, or both, when performed by either the medical practitioner or the laboratory; The following laboratory tests: Hemoglobin or hematocrit, or both; Urinalysis for albumin sugar; Urine culture and sensitivity studies; Appropriate laboratory tests to screen for sexually transmitted infections; Smear wet mount and KOH with interpretation; Rubella titer of females without documentation of prior rubella immunization; and Pap smear; Pharmaceutical supplies and devices: To prevent conception through chemical, mechanical, or other methods, which are covered by the Maryland Medical Assistance Program under COMAR 10.09.03.04; and To treat sexually transmitted infections when diagnosed during the course of an office visit, as outlined in §A of this regulation, which are covered under COMAR 10.09.03.04 except treatment for: Human immunodeficiency virus; and Hepatitis. Permanent sterilization only when performed according to criteria in 42 CFR Part 441, Subpart F, Sterilizations, as amended, and when the appropriate forms are: Properly completed; and Available in the medical record for review; Human papillomavirus vaccine; and Abortions performed in accordance with Health-General Article, §15-103, Annotated Code of Maryland. The following services are not covered: Services not medically necessary; Transportation services; EPSDT services; Services delivered in an in-patient hospital setting or ambulatory surgical center other than: Permanent sterilizations; and A hysterosalpingogram following the Essure procedure; Infertility services, including reversal of sterilization; and Any service not listed in Regulation .05 of this chapter. Limitations for advanced practice nurse services covered under this chapter are those set forth in COMAR 10.09.01.05. Limitations for physician services covered under this chapter are those set forth in COMAR 10.09.02.05. Limitations for free-standing clinic services covered under this chapter are those set forth in COMAR 10.09.08.07. Limitations for pharmacy services covered under this chapter are those set forth in COMAR 10.09.03.05. Limitations for medical laboratory services covered under this chapter are those set forth in COMAR 10.09.09.05. Limitations for acute hospital services covered under this chapter are those set forth in COMAR 10.09.92.05. Limitations for physician assistant services covered under this chapter are those set forth in COMAR 10.09.55.05. Limitations for ambulatory surgery centers covered under this chapter are those set forth in COMAR 10.09.42.05. Payment procedures are those set forth in COMAR 10.09.36.04. Billing time limitations are those set forth in COMAR 10.09.36.06. Payment procedures for advanced practice nurses are those set forth in COMAR 10.09.01.06. Payment procedures for physician services in the office or home are those set forth in COMAR 10.09.02.07. Payment procedures for clinic services delivered in federally qualified health centers are those set forth in COMAR 10.09.08.05. Payment procedures for clinic services delivered in local health departments, family planning clinics, and other free-standing clinics are those set forth in COMAR 10.09.02.07. Payment procedures for pharmacy services are those set forth in COMAR 10.09.03.07. Payment procedures for medical laboratory services are those set forth in COMAR 10.09.09.07. Payment procedures for acute hospital services are those set forth in COMAR 10.09.92.07. Payment procedures for physician assistant services are those set forth in COMAR 10.09.55.06. Payment procedures for ambulatory surgery centers are those set forth in COMAR 10.09.42.06. Recovery and reimbursement are as set forth in COMAR 10.09.36.07. Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. The requirements related to appeal procedures under COMAR 10.09.36 and 10.09.37 apply to this chapter. The requirements relating to fraud and abuse under COMAR 10.09.24.14 shall apply to this chapter. State regulations are interpreted as set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: Regulations .01—.12 adopted as an emergency provision effective October 19, 1994 (21:23 Md. R. 1930); adopted permanently effective April 10, 1995 (22:7 Md. R. 536) Regulation .01B, C amended as an emergency provision effective July 1, 2003 (30:17 Md. R. 1202); amended permanently effective October 13, 2003 (30:20 Md. R. 1448) Regulation .01B, C amended effective January 12, 2009 (36:1 Md. R. 21) Regulation .01 repealed and new Regulation .01 adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); adopted permanently effective June 11, 2012 (39:11 Md. R. 686) Regulation .01B amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .02B amended effective August 27, 2007 (34:17 Md. R. 1507) Regulation .02B amended as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686) Regulation .02B amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .03 amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .04 amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .04D adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686) Regulation .05A, D, E amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .05F amended effective January 12, 2009 (36:1 Md. R. 21); March 31, 2025 (52:6 Md. R. 267) Regulation .05F amended as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686) Regulation .05G amended effective March 31, 2025 (52:6 Md. R. 267) Regulation .05H adopted effective March 31, 2025 (52:6 Md. R. 267) Regulation .06 amended effective December 31, 2018 (45:26 Md. R. 1243) Regulation .06A amended effective August 27, 2007 (34:17 Md. R. 1507); March 31, 2025 (52:6 Md. R. 267) Regulation .06A amended as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686) Regulation .07 amended effective June 11, 2012 (39:11 Md. R. 686); December 31, 2018 (45:26 Md. R. 1243) Regulation .10 repealed and new Regulation .10 adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); adopted permanently effective June 11, 2012 (39:11 Md. R. 686)